BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AO CAST SAW

    MDR report key: 7453806 · Received April 24, 2018

    Report

    Report Number
    7453806
    Event Type
    Malfunction
    Date Received
    April 24, 2018
    Date of Event
    March 29, 2018
    Report Date
    April 18, 2018
    Manufacturer
    BSN MEDICAL INC.
    Product Code
    LGH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CAST SAW MALFUNCTIONED AND CUT THE PATIENT'S SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296653 AO CAST SAW INSTRUMENT, CAST REMOVAL, AC-POWERED LGH BSN MEDICAL INC. 0295-200 74470-10

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR